Assess Safety and Efficacy of Vilaprisan in Subjects with Uterine Fibroids
- Conditions
- eiomyomaMedDRA version: 20.0 Level: LLT Classification code 10046784 Term: Uterine fibroids System Organ Class: 100000004864MedDRA version: 20.0 Level: LLT Classification code 10016628 Term: Fibroids System Organ Class: 100000004864MedDRA version: 20.0 Level: LLT Classification code 10022794 Term: Intramural leiomyoma of uterus System Organ Class: 100000004864Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2016-002855-48-GB
- Lead Sponsor
- Bayer AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 1200
1. Signed and dated informed consent
2. Women, 18 years or older at the time of Visit 1
3. Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter 30 mm
4. The largest diameter of any uterine fibroid < 120 mm
5. Heavy menstrual bleeding (HMB) > 80.00 mL documented by menstrual pictogram (MP) in a bleeding period during the screening period
Women who did not suffer from perceived HMB during the 3 months prior to Visit 1 due to any effective medical treatment, eg, with a hormonal contraceptive, are not considered appropriate candidates and should not undergo further screening procedures.
Women suffering from perceived HMB despite medical treatment, eg, with a hormonal contraceptive, are appropriate candidates for further screening, if rules on stopping prior
medication (see exclusion criterion 7) are followed.
Heavy menstrual bleeding (HMB) > 80.00 mL should be documented within 10 consecutive days. As a guidance, the duration of a bleeding episode should not exceed 12 days.
6. Good general health (except for findings related to uterine fibroids) as proven by medical history, physical and gynecological examinations, and laboratory test results
7. Normal or clinically insignificant cervical smear not requiring further follow-up. The cervical smear may be waived if a normal result has been documented in the subject’s
medical records within the previous 6 months.
Human papilloma virus (HPV) testing in subjects with atypical squamous cells of undetermined significance (ASCUS) can be used as an adjunctive test. Subjects with
ASCUS can be included if they are negative for high-risk HPV strains.
8. An endometrial biopsy performed during the screening period, without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or
other significant endometrial pathology. If the sample is inadequate, the biopsy can be repeated once within the screening period and must be repeated within 6 weeks from the
first biopsy in order for the subject to continue. No further repeated biopsies for inadequate samples are permitted.
9. Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1 until the end of the study. (Short-acting hormonal contraception [oral, vaginal, or transdermal] are allowed up until the start of the menstrual cycle that follows Visit 1.) This is not required if contraception is achieved by a permanent method, such as bilateral fallopian tube blockage of the subject (including Essure®) or vasectomy of the partner(s).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
2. Hypersensitivity to any ingredient of the study drugs
3. Hemoglobin values =6 g/dL or any condition requiring immediate blood transfusion (subjects with haemoglobin values =10.9 g/dL will be recommended to use iron supplementation).
4. Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug including, but not limited to:
• Impaired function of the kidneys (laboratory values outside of inclusion range)
• Abnormal liver parameters (presence of at least one of the following criteria please see also Section 9.6.3.1 Laboratory evaluations):
- 2 x upper limit of normal (ULN) for glutamic oxaloacetic transaminase (GOT) / aspartate aminotransferase (AST)
- 2 x ULN for glutamic pyruvic transaminase (GPT) / alanine aminotransferase (ALT)
- 2 x ULN for alkaline phosphatase (AP)
- Total bilirubin outside the upper limit of normal
- International normalized ratio (INR) outside the upper limit of the normal range
• Diagnosis of hepatitis B infection, i.e., Hbs-antigen positive at Visit 1
• Diagnosis of hepatitis C infection, i.e., hepatitis C-antibodies and HCVRNA positive at Visit 1
• Chronic bowel diseases, eg, M. Crohn and Colitis ulcerosa
• Intake of strong cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors within the last 2 weeks before the randomisation visit and during the treatment period, including: antivirals (eg, viekira pak, telaprevir, boceprevir), protease inhibitors (eg, ritonavir, lopinavir, indinavir, nelfinavir, saquinavir), antifungals (eg, itraconazole, voriconazole, posaconazole), antibiotics (eg, clarithromycin, telithromycin), grapefruit and any grapefruit containing food products (eg, grapefruit juice). Ketoconazole and other triazole antifungal drugs are allowed for topical/local use (including vaginal application).
• Intake of strong CYP3A4 inducers (eg, rifampicin, carbamazepine, phenytoin, phenobarbital, St John´s wort [hypericum]) within the last 2 weeks before
the randomization visit and during the treatment period.
5. Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results, including
• Known severe coagulation disorder
• Known anemia for reason other than HMB
• Known hemoglobinopathy
• History of or current uterine, cervical, ovarian or breast cancer (except cervical cancer after curative treatment)
• One or more ovarian cysts >30 mm in diameter as measured by ultrasound (except endometrioma)
• Any ovarian tumors or pelvic masses of unclear etiology requiring further diagnostic procedures
• Known or suspected uterine polyp >15 mm
6. Abuse of alcohol, drugs, or medicines (eg, laxatives)
7. Use of other treatments that might interfere with the conduct of the study or the interpretation of the results including
• Short-actin
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to assess the efficacy of vilaprisan in subjects with uterine fibroids compared to ulipristal.;Secondary Objective: The secondary objective of this study is to evaluate the efficacy and safety of different treatment regimens of vilaprisan in subjects with uterine fibroids ;Primary end point(s): Amenorrhea (yes/no), Defined as menstrual blood loss (MBL) < 2 mL based on the menstrual pictogram (MP) during last 28 days ;Timepoint(s) of evaluation of this end point: For the primary analysis of the primary variable, the amenorrhea rates after 12 weeks of treatment in Groups A1, A2 and A3 will be compared to the rate from Group B.
- Secondary Outcome Measures
Name Time Method